Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

NCT04261478 | Recruiting DMC FDA Device

• 1 other identifier: MP-02-2020-8614
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc. Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking. EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).

Conditions

Stroke, Acute; Carotid Stenosis; Carotid Artery Diseases

Keywords

Thrombectomy; Tandem occlusion; Carotid stenting

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)

  The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.

  90 days ± 14 days

Secondary Outcomes (11)

• Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex

  90 days ± 14 days

• Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)

  90 days ± 14 days

• Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score

  24 hours ± 8 hours

• Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score

  90 days ± 14 days

• Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score

  90 days ± 14 days

Other Outcomes (13)

• Safety outcome: Proportion of patients with any intracranial hemorrhage (ICH)

  24 hours ± 8 hours

• Safety outcome: Proportion of patients with a symptomatic intracranial hemorrhage (sICH)

  24 hours ± 8 hours

• Safety outcome: Proportion of patients with death of any cause

  90 days ± 14 days

Study Arms (2)

Acute Stenting

ACTIVE COMPARATOR

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.

Device: Carotid artery stenting; Drug: Antiplatelet Agents

No Acute Stenting

NO INTERVENTION

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.

Interventions

Carotid artery stenting DEVICE

The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.

Also known as: Stenting

Acute Stenting

Antiplatelet Agents DRUG

The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors, periprocedural IV Heparin is discouraged.

Acute Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:
• Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)
• A neurological deficit judged to be disabling by the patient and/or treating physician
• Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT
• Groin puncture within 24-hours of onset or last known normal
• Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging
• Informed consent from patient or surrogate or deferral of consent, according to local ethics policies

You may not qualify if:

• Pre-existing neurological impairment (modified Rankin score ≥3)
• Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely
• Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy
• Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography
• Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection
• Isolated cervical carotid occlusion without intracranial occlusion
• Pregnancy

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• McGill University: collaborator
• Laval University: collaborator
• Queen's University: collaborator
• University of Ottawa: collaborator
• McMaster University: collaborator
• University of Calgary: collaborator
• University of British Columbia: collaborator
• Dalhousie University: collaborator
• Health Sciences North Research Institute: collaborator
• University of Toronto: collaborator
• University of Alberta: collaborator
• Canadian Stroke Consortium (CSC): collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Stroke; Carotid Stenosis; Carotid Artery Diseases

Interventions

Stents; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Alexandre Y Poppe, MD CM

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Y Poppe, MD CM

CONTACT

5148908000; alexandre.poppe.med@ssss.gouv.qc.ca

Nandy Simon, BSc

CONTACT

5148908000; nandy-shelwine.simon.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label, blinded endpoint (PROBE)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 7, 2020
• Study Start: August 31, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
• Access Criteria: These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.

Locations

CA (1)